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Surgical Instrument Traceability - Full Case Study

Safer Surgery Saves Lives

The Health Service Executive (HSE) is the government agency responsible for the provision of public healthcare services for everyone living in Ireland. The HSE now requires that all surgical instrument trays are identified using GS1 Standards to enable stakeholders to track and trace them throughout the supply chain. The system currently being rolled out is designed to create a collaborative, interoperable, and nationwide traceability solution for Central Decontamination Units.

There is well documented evidence highlighting the importance of effective decontamination processes to prevent the spread of infections. The Medical Devices Directive (93/42/EEC) specifies the minimum standards in relation to decontamination of Reusable Invasive Medical Devices. Hospital acquired infections are a concern for all hospitals and their patients as Surgical Site Infections (SSIs) can have an impact on both patient safety (e.g., development of a serious illness) and hospital costs (e.g., additional cost of treatment for the patient).

The importance of a robust track and trace system that complies with regional, national and international best practices for the decontamination of surgical instrument sets is recognised as an integral part of all Central Decontamination Units (CDUs). Under the current economic and budgetary pressures that are faced by most health services across the globe, including Ireland, there is often a need to share important hospital resources such as surgical instrument sets. There is also a significant market for manufacturers to loan instrument sets to hospitals for specific procedures because it is not cost effective for a hospital to purchase them.